Quality Engineer
About The Position
Position Summary: The Quality Engineer performs a variety of quality-related functions in support of regulatory, customer, and company requirements/objectives. In collaboration with the Quality Assurance Manager and the quality team, they will coordinate, develop, monitor, and maintain all necessary procedures, controls, and/or programs to assure compliance with regulatory, customer and company requirements. This position will also support the functions of the Quality Assurance Department to meet the requirements of the relevant ISO 9001:2015 standards based on the quality objectives established by Top Management.
Requirements
- Bachelor’s degree in Quality, Technology, Manufacturing, Mechanical, or related technical field.
- 5+ years’ equivalent experience in a Quality Engineering, Quality Assurance, or Quality Control role, or, 3+ years’ equivalent experience with a Graduate degree.
- Working knowledge of quality management systems (QMS).
- Experience with root cause analysis and corrective/preventive action (CAPA) methodologies.
- Proficiency in quality tools and techniques (e.g., SPC, FMEA, control plans, Pareto analysis, 8D).
- Ability to read and interpret engineering drawings, specifications, and technical documentation.
- Experience conducting internal audits and supporting external customer or regulatory audits.
- Strong analytical, problem-solving, and organizational skills.
- Proficiency with Microsoft Office (Excel, Word, PowerPoint) and basic data analysis
Nice To Haves
- Master’s degree in Engineering, Quality, or a related technical field.
- Quality certification such as CQE, CQA, Six Sigma Green Belt or Black Belt.
- Experience in a regulated industry (medical devices, aerospace, automotive, defense, pharmaceutical).
- Knowledge of statistical analysis software (e.g., Minitab, JMP).
- Familiarity with risk management standards (e.g., ISO 14971).
- Hands-on experience with process validation, PPAP, APQP, or production launch support.
- Knowledge of Lean manufacturing principles and continuous improvement methodologies.
Responsibilities
- Lead or perform product quality audits to assure compliance with customer, drawing, internal, and regulatory requirements.
- Lead or perform system audits in support of the Quality Management System.
- Provides liaison activities with customers and suppliers on all quality issues.
- Perform review of customer quality documents.
- Support operations to ensure that products and processes comply with the relevant requirements of the quality management system.
- Analyze product and process failures to ensure effective root cause analysis and implementation of corrective and preventive actions for customers.
- Review trend analyses related to field returns, MRBs, supplier defects and provide recommendations for improvement.
- Participate or lead root cause corrective action investigations and implementation to address internal, external, customer and/or supplier issues to improve overall product and process quality.
- Participate in Engineering and Operations to ensure transfer to Production of new products are in accordance with approved data.
- Responsible for leading and/or participating in continual improvement activities to enhance the quality system.
- Meets required ISO 9001:2015 standards and necessary training based on the relevant Quality Objectives.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
11-50 employees
